RecruitingPhase 1NCT05610865

Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds

Sponsor

University of the Punjab

Enrollment

28 participants

Start Date

Nov 20, 2020

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Diabetic Foot Ulcer Diabetic Foot Foot Ulcer Due to Type 2 Diabetes Mellitus Foot Ulcer Diabetes Complications Foot Ulcer Due to Type 1 Diabetes Mellitus Diabetic Foot Infection Diabetic Foot Ulcer Neuropathic Chronic Diabetic Ulcer of Left Foot Chronic Diabetic Foot Ulcer of Right Foot

Summary

The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.

Eligibility

Min Age: 20 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether stem cells taken from the patient's own fat tissue (adipose-derived stem cells) can help heal chronic diabetic foot ulcers — wounds on the feet that don't heal well due to diabetes-related nerve and circulation damage. **You may be eligible if...** - You are between 20 and 60 years old (male or female) - You have type 1 or type 2 diabetes - Your BMI is between 20 and 30 (suitable for the fat tissue collection procedure) - You have a chronic foot ulcer that has been present for 6–24 weeks, with a wound area of 2–8 cm² - Your wound is Wagner Grade I (limited to soft tissue, not bone) - You have adequate blood circulation to the feet and are already using an off-loading method (special footwear or device) **You may NOT be eligible if...** - You have uncontrolled high blood sugar - Your wound is deeper than Grade I (involves bone or tendon) - You have poor circulation below the threshold required - You are not suitable for liposuction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERControl; Standard-of-care management

Patients will undergo conventional wound care management.

BIOLOGICALOnly PRP injection

Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.

BIOLOGICALPRP + SVF injection

Uncultured cells (SVF) along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

BIOLOGICALPRP + ASCs injection

Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Locations(1)

Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)

Lahore, Punjab Province, Pakistan

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NCT05610865

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